IronMag Bodybuilding Forums - Supplementshttp://www.ironmagazineforums.com/
enSun, 18 Feb 2018 05:09:38 GMTvBulletin60http://www.ironmagazineforums.com/images/SeamusLight/misc/rss.pngIronMag Bodybuilding Forums - Supplementshttp://www.ironmagazineforums.com/
Water Intakehttp://www.ironmagazineforums.com/threads/220807-Water-Intake?goto=newpost
Wed, 14 Feb 2018 16:57:29 GMTI just heard a fitness trainer at my gym tell a small group of people that drinking a gallon of water is equivalent to running two miles.
No way...I just heard a fitness trainer at my gym tell a small group of people that drinking a gallon of water is equivalent to running two miles.

No way this could be true.. right?

Can someone enlighten me so I can stop this flow of nonsense at my gym!
]]>Supplementsajbrooks1http://www.ironmagazineforums.com/threads/220807-Water-IntakeHow LGD-4033 Workshttp://www.ironmagazineforums.com/threads/220806-How-LGD-4033-Works?goto=newpost
Wed, 14 Feb 2018 13:48:27 GMTLGD-4033 performs by attaching androgen receptors promptly. It reveals anabolic activity in the bone fragments and muscles instead of harmfully...LGD-4033 performs by attaching androgen receptors promptly. It reveals anabolic activity in the bone fragments and muscles instead of harmfully impacting the prostate and skin sebaceous glands which usually happens when using steroids.
LGD-4033 is linked to a study called Stage I Several Climbing Amount such as fit volunteers. This was an unexpected, double combine research stage that involved a sugar pill. The potential was to type that using LGD-4033 was safe and easy to stomach with a dose not beyond 22 mg a day.

Editor?s note:This is the second in a two-part series examining violations of cGMPs (current good manufacturing practices) in fiscal year 2017 (FY17) based on data INSIDER obtained through a Freedom of Information Act (FOIA) request.

Manufacturers of dietary supplements in the United States are struggling with requirements to establish production and process controls to verify the quality of their products.

The production and process controls requirements reflect ?the most poorly understood section? of FDA?s 10-year-old cGMPs, said Vasilios (?Bill?) Frankos, Ph.D., an Herbalife Nutrition executive and former FDA official who oversaw implementation of the dietary supplement manufacturing regulations after they were adopted in 2007.

Of the cGMP ?observations? or violations reported by FDA investigators in FY17, Frankos found through an analysis that roughly one-third related to the above requirements, which are incorporated in subpart E of 21 C.F.R. 111. Likewise, a separate analysis by INSIDER determined around 600 of the nearly 1,800 cGMP observations reported by FDA in FY17 were based on the production and process control requirements.

Nearly half (45 percent) of FDA?s total observations were based on requirements in subpart E and obligations in a different section of the regulations (subpart F) to establish and follow written procedures for the responsibilities of quality control (QC) operations. Frankos reached a similar conclusion after he analyzed FDA cGMP inspection data INSIDER obtained.

?The smaller companies need to redouble their effort and focus on subparts E and F of the GMPs,? observed Frankos, who is responsible for product science, safety and compliance at Herbalife Nutrition. ?Those are the sections that really require you to have some expertise in quality control, analytical chemistry [and] being able to establish specifications. And it probably is the part of the process that requires the most ? technical expertise.?

Commenting in December on the cGMP data, an FDA official said companies are still coming up short meeting fundamental requirements.

?Unfortunately, what we?re still seeing is that the most frequently reported observations during the inspections are deficiencies in some of the fundamental aspects of the cGMP compliance system," said Cara Welch, Ph.D., senior advisor to FDA?s Office of Dietary Supplement Programs (ODSP).

In discussing cGMP violations fundamental to the 10-year-old regulations, Welch referenced failure to establish and meet product specifications, failure to establish and follow written procedures for QC operations, and deficiencies related to batch production records and master manufacturing records.

Of those companies inspected in FY17, 58 percent?379 facilities?received an inspection report from FDA for alleged violations of the cGMPs.

?GMPs create, for me, kind of a yin and a yang,? said Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), in a phone interview. ?On the one hand, you don?t want to see unnecessary expense layered into these products. If it?s simply the cost of compliance and then you end up driving smaller entrepreneurial firms out, you don?t want that to happen. But on the other hand, every single dietary supplement that goes into the marketplace has to be safe. Any one product has the potential to create a problem that creates a shadow over the entire industry.?

Former FDA investigator Larisa Pavlick described some of the essential cGMP requirements and what her former employer wanted to see during an audit.

?There has to be a written document established and implemented to describe ? the major characteristics of a product that are used to measure quality before it?s released,? Pavlick, vice president of global regulatory and compliance with the United Natural Products Alliance (UNPA), said in a phone interview. ?From FDA?s perspective, they want to know, ?What is the identity of the raw materials? Are you ensuring that you have the appropriate plant or vitamin and minerals at the appropriate strength during [the] formulation and blending process???

FDA auditors also want to view documentation establishing a dietary supplement is manufactured the same way every time, and sufficient controls are in place to ensure the formula matches what?s printed on the label, Pavlick said.

Commenting on the requirement to establish products specifications, Pavlick acknowledged supplement manufacturers still need assistance understanding FDA?s expectations. Her assertion is backed by FDA data. In FY17, the most common cGMP observation was failure to establish product specifications for the identity, purity, strength and composition of the finished dietary supplement, and set limits on contaminants. The requirement (21 C.F.R. 111.70(e)) is found in subpart E of the regulations.

During her work as an FDA investigator, Pavlick said many companies that established specifications would include physical characteristics of products, such as their appearance and chemistry. However, she explained, they neglected to define elements required by the regulation, such as the specs governing the identity and purity of the supplement.

Some companies, Pavlick added, may have some written documentation, but not everything FDA is looking for. For example, while a batch record may include details of a specification, a company may not have taken the time to separately write the actual spec, Pavlick noted.

Many FDA ?investigators are looking for a specific document that?s titled ?specification,? and they?re looking for that for the specific product that they?ve randomly selected during the audit,? the former FDA employee explained.

Pieter Cohen, M.D., is an associate professor of medicine at Harvard Medical School and renowned critic of the regulatory framework governing supplements in the United States. He said there was an assumption a few years ago that many manufacturers receiving an FDA inspection report were adjusting to the cGMPs, reflecting a high learning curve.

?With the continued failure of the majority of firms to comply with the most basic aspects of [the cGMPs], however, it has now become clear that, as a whole, supplement manufacturers are unwilling to take responsibility for the quality of what they sell," Cohen said in an emailed statement.

The physician, whose research has uncovered potentially hazardous ingredients in products marketed as dietary supplements, described FDA's manufacturing requirements as "extremely basic," but he said "the industry has been unwilling to comply with the most basic requirements to ensure consumer safety.?

FDA data suggests large manufacturers with at least 500 employees have a firmer grasp of the regulations than smaller companies. None of the large companies inspected by FDA in FY17 were assigned a classification (?official action indicated?) reflecting significant regulatory violations, according to data INSIDER obtained in November 2017 from FDA through an FOIA request.

(Responding to the FOIA request, FDA officials cautioned that some regulatory classifications had not been finalized [total cGMP inspections: 656; regulatory classifications: 523]).

?The big companies are spending money on a lot of new equipment,? Frankos said, ?and what you?re seeing is they are not having any real problems in meeting the subparts E or F because they?ve committed the resources and they?ve hired the technical staff.?

Mister didn?t offer a simple explanation when asked about the perceived disparity in regulatory compliance between smaller companies and large firms.

?It would be easy to just say it?s a matter of resources, but I think you?ve got to look more than that,? he said. ?Is it expertise? Is it that in smaller firms, your head of [quality assurance (QA) and QC] is also wearing other hats, so do they really have the expertise and the time to fully understand what?s required?

?It?s also possible that some smaller firms ? are still putting their heads in the sand and hoping that they don?t get caught,? Mister added. ?And I?m not saying that is the case, but I think you have to consider all those possibilities.?

Frankos said it?s time for FDA to hold targeted, ?hands-on? and ?intensive? training sessions focused on specific areas of the cGMPs, including subparts E and F. Some of the training, he explained, requires education in a laboratory setting to review such technical areas as calibrating equipment.

In interviews with the media and at trade shows, UNPA member conferences and other events, Pavlick highlights common cGMP observations, and the former FDA investigator recommends potential solutions. The good news for supplement manufacturers is that many issues identified by FDA during cGMP inspections may not require technical expertise and vast investments in QC.

?Written procedures are easy to implement,? Pavlick said, commenting on some of the most frequently cited cGMP infractions in FY17, ?and I think that?s going to be something that we can pretty quickly educate members and the industry at large on how to make that correction.?

ANDRO HARD? ? ROCK HARD ABS, CHISELED CHEST, GET HARD!
Super R-Andro? Now delivered in a topical gel. Andro Hard will transform you! For many years androsterone was considered the primary male hormone until testosterone was discovered from concentrated testicular extracts many years later. The strongest naturally occurring androgen is dihydrotestosterone (DHT). Only AndroHard contains Super-R-DHEA (androsterone enanthate) ? a highly bio-available, 5a-reduced metabolite of DHEA ? which sky rockets DHT levels within 3 hours of

GEAR? ? ?EXERCISE IN A BOTTLE!??
Stenabolic has the ability to alter the activity of the skeletal muscle mitochondria, or in simple terms ? it boosts your metabolic activity. This makes it similar to what the drug DNP does, but being much safer and not counter productive to your endurance goals. What?s more unlike DNP Stenabolic has the ability to mimic actual aerobic exercise without actually putting in the conditioning. Therefore, it will boost your endurance instead of hurting it!
Testolone was designed to behave like the hormone testosterone in the body, but its not a hormone and has no negative/androgenic side effects that steroids have. It does this by having a massive 85:1 anabolic to androgenic ratio causing the body to burn fat and build lean muscle mass (anabolism) at an extraordinary rate comparable to anabolic steroid use.

About 5 million U.S. adults and 1 million U.S. children use homeopathy every year, and the remedies are known to be ?generally safe and unlikely to cause severe adverse reactions,? according to the U.S. National Institutes of Health?s National Center for Complementary and Integrative Health.1 Yet, if the U.S. Food and Drug Administration (FDA) continues on its latest crusade, this natural health modality may soon be much harder to come by.

In a draft guidance document released in December 2017, the FDA takes aim at homeopathic remedies, or as they put it, ?drug products labeled as homeopathic.?2,3 In a reversal of a long-standing decision to treat homeopathic remedies differently from other drugs, the FDA has now labeled virtually all of these products as ?new drugs? that are ?subject to FDA enforcement action at any time.?

FDA Declares Homeopathic Drugs Illegal, Plans to Ramp Up Enforcement Actions
While deaths from drugs like opioids are now a public health crisis, homeopathy has maintained a much lower, and presumably safer, profile. Yet, the FDA is using its limited resources to target the latter, citing a need to ?protect consumers who choose to use homeopathic products.? Why now? The FDA also cited a ?large uptick in products labeled as homeopathic that are being marketed for a wide array of diseases and conditions,? to the extent that homeopathic products are now a close to $3 billion industry.4

Perhaps that?s $3 billion too much for Big Pharma, FDA?s cozy partner in crime. ?[I]n one fell swoop, the FDA has declared that virtually every single homeopathic drug on the market is being sold illegally,? the Alliance for Natural Health USA (ANH USA) wrote5 ? and it?s not an exaggeration. In essence, the FDA?s guidance reads:6

Any homeopathic drug that has not been considered ?generally recognized as safe and effective? (GRAS/E) is considered a new drug
FDA has not determined that any homeopathic drugs are GRAS/E
A new drug cannot be marketed unless it goes through the FDA?s approval process
No homeopathic drugs have gone through FDA approval nor can any producer afford to take them through the approval process
The FDA then states that it?s proposing a ?new, risk-based enforcement approach? and first plans to target the ?unapproved drug products labeled as homeopathic that have the greatest potential to cause risk to patients.? This includes:7

Products intended to be used for the prevention or treatment of serious and/or life-threatening diseases and conditions

Products for vulnerable populations

Products that do not meet standards of quality, strength or purity as required under the law

FDA Does About-Face, ?Penalizes an Entire Industry?
The draft guidance is a complete turnaround from the FDA?s prior stance on homeopathic remedies, which stated, under the 1988 Compliance Policy Guide (CPG) 400.400, Conditions Under Which Homeopathic Drugs May be Marketed, they did not need to get FDA approval prior to coming on the market. Instead, the ingredients in homeopathic remedies were to be verified by the Homeopathic Pharmacopoeia of the United States (HPUS). As noted by law firm Venable:8

?Essentially, the HPUS creates a monograph for homeopathic drugs to follow, not dissimilar to the OTC drug monographs that FDA has developed for allopathic drugs. Accordingly, by virtue of an ingredient?s inclusion in the HPUS, the ingredient has already been closely examined and determined to be safe and effective by the HPCUS [Homeopathic Pharmacopoeia Convention of the United States].

Compliance with the HPUS functions as a premarket review of safety and effectiveness in the homeopathic context. By classifying homeopathic drugs as unapproved new drugs, the FDA is requiring a second showing of safety and effectiveness, a step that is unnecessary, not to mention impractical, given that the Agency intends to hold homeopathic products to an allopathic standard that is inappropriate, given the nature of homeopathic products.?

Further, it was by the FDA?s own deliberate decision that homeopathic drugs were excluded from former drug approval processes and intended to be a separate category. Venable continued:9

?The FDA deliberately excluded homeopathic drugs from both the Drug Efficacy Study Implementation (DESI) review (the process by which all drugs approved between 1938 and 1962 were retrospectively evaluated by the FDA for effectiveness) and the OTC Drug Review in 1972 (the process used to develop OTC drug monographs for allopathic drugs), deciding instead in the latter case to regulate homeopathic products separately because of their uniqueness.

By withdrawing the CPG and classifying all homeopathic drugs as unapproved drugs subject to FDA drug approval, the FDA is now requiring higher regulatory thresholds for OTC homeopathic drugs than are applicable to allopathic OTC drugs, many of which are permitted to be sold pursuant to the FDA monograph system. This move in effect penalizes an entire industry for the Agency?s 1972 decision.?

FTC Targeted Homeopathy in 2016
The FDA isn?t the first government agency to target this centuries? old natural medicine system. In a notice filed in November 2016, the FTC stated that in order for homeopathic remedies to claim they are effective, their makers must provide proof. If no proof is provided, the remedies must state there is ?no scientific evidence that the product works.?

In order to not mislead consumers, the FTC further stated that homeopathic remedies lacking sufficient proof must communicate to consumers that ?the product?s claims are based only on theories of homeopathy from the 1700s that are not accepted by most modern medical experts.?10 Dana Ullman, MPH, CCH, one of the leading advocates for homeopathy in the U.S., said at the time:11

?Considering the longtime safety history of homeopathic medicines, it is surprising and even shocking that the FTC would consider proposing new regulations now.

One cannot help but wonder who or what is pulling their strings ? policies ? commonly result from powerful economic forces at play ? it is clear that this governmental agency is ignoring important scientific evidence, and one must wonder if they are protecting Big Pharma from competition more than protecting the consumer.?

Does Homeopathy Work?
Based on the theory that ?like cures like,? or the Law of Similars, homeopathy was founded by German physician Dr. Samuel Hahnemann. The idea is that health conditions can be healed by treating a person with minute doses of a substance that would produce similar symptoms to their health condition if given in larger doses.

Homeopathy?s other guiding principle is that of the minimum dose, which is based on the premise that the more a substance is diluted, the more potent homeopathic remedy it becomes, known as the ?law of infinitesimals.? Homeopathic remedies may be made from plants, minerals or other substances and are commonly administered in pellet form, dissolved under the tongue. A number of intriguing studies suggest homeopathy is effective and safe for a variety of ailments, including flu. According to Ullman:

?The use of a homeopathic medicine called Oscillococcinum is an example of a remedy that can be effective for many people with the flu, though clinical experience suggests that it is most effective when used within 48 hours of getting flu symptoms. Although most homeopathic medicines are made from the plant or mineral kingdom, Oscillococcinum is unusual in that it is made from the heart and liver of a duck.?

In one study, nearly twice as many patients who were given Oscillococcinum recovered from the flu within 48 hours as those given a placebo.12 Further, Ullman noted:

?A different group of researchers conducted a randomized, double-blind study involving 372 patients (188 treated with Oscillococcinum and 187 with placebo) of both sexes, ranging in age from 12 to 60, who presented rectal temperature ≥ 100.4 F, muscle pains, headache, or at least one of the following symptoms: shivering, chest pain, spine pain, coughing, irritation of nasal mucosa or feeling of malaise.13

Patients received three tubes of Oscillococcinum or placebo each day (morning, noon and night) for three days. The results of this trial show a highly statistically significant difference between the two groups, for what concerns disappearance of symptoms after 48 hours (19.2 percent in the Oscillococcinum group versus 17.1 percent in the placebo group) and improvement in symptoms (43.7 percent versus 38.6 percent for placebo).?

Additional research shows homeopathy?s promising role in the following conditions:

In patients with allergies, those using homeopathy reported improvements in nasal airflow compared with a placebo group.

With homeopathic treatment, the researchers described a ?clear, significant and clinically relevant improvement in nasal inspiratory peak flow, similar to that found with topical steroids.?14

Homeopathy significantly reduced the severity and duration of chemotherapy-induced stomatitis (swelling and sores in the mouth) in children.15

Homeopathic medicine was effective in treating acute childhood diarrhea, decreasing both the duration of the diarrhea and the number of stools per day.16,17

Homeopathy has positive effects in children with attention deficit hyperactivity disorder (ADHD), particularly in the areas of behavioral and cognitive functions.18

Homeopathy lessened tender point pain and improved quality of life in people with fibromyalgia.19

Homeopathic was effective in treating the early stages of vitiligo in a report of 14 cases20

FDA Continues to Crack Down on Natural Substances, Protect Big Pharma
The FDA?s new push to regulate homeopathic products is eerily reminiscent of their recent crackdown on the plant kratom. Leaves from the kratom tree have been used for pain relief for hundreds of years, but scientists now know they contain compounds that target the brain similarly to opioids, helping to relieve pain. It appears the plant may be safer than opioids for pain relief and could even act as a tool to help those suffering from opioid withdrawal.

In November 2017, however, rather than targeting the prescription opioids that are the root of the opioid epidemic, the FDA issued a public health advisory regarding risks associated with kratom use, suggesting that its usage could ?expand the opioid epidemic.? What this comes down to, for some, is the right to choose what form of ?medicine? to put in your body. As Dr. Lee Hieb, an orthopedic surgeon and past president of the Association of American Physicians and Surgeons, wrote in WND:21

?I?m not here to tout any particular over-the-counter remedy, but who gave the FDA total ability to limit what we can take into our bodies, while virtually forcing us to be given what they prescribe? It?s none of their business whether a ?homeopathic remedy? is worthless.

That?s an issue of commerce and truth in advertising. I, for one, want the freedom to research and decide for myself what supplements to take, even if my supplements ultimately do me no good. (Many do a great deal of good as Big Pharma knows only too well.)?

People have the right to choose their treatment, and doctors (many of whom admit to prescribing placebos to their patients) also retain the right to offer treatments they deem useful, whether it be homeopathy or another remedy.

As for the FDA?s new draft guidance on homeopathic drugs, it?s attempting to discredit such remedies? proven healing powers before their mechanisms of action have even been fully understood. If you want to express your opinion on the matter, the FDA is accepting comments from the public until March 30, 2018.

In November 2017, a biopharmaceutical company urged a federal appeals court to reverse a district court ruling involving competitors in the sports supplement industry. The "primary jurisdiction" ruling formed the basis for the dismissal of a lawsuit filed by one sports supplement marketer against a rival supplement business.

GTx Inc. didn't comment on the merits of a lawsuit involving the purported sale of ostarine in supplements. Instead, the Memphis, Tennessee-based company agreed with the plaintiff, Nutrition Distribution LLC, that its complaint was improperly dismissed based on the legal doctrine known as primary jurisdiction.

Under the doctrine, courts sometimes refrain from ruling on claims until an administrative agency like FDA first decides an issue within its expertise.

It's unusual for a pharmaceutical firm to formally meddle in private litigation between two marketers of supplements; but, GTx has invested in the development of a SARM (selective androgen receptor modulator) at the heart of the lawsuit: enobosarm, also known as ostarine or MK-2866. GTx is developing ostarine to treat breast cancer, Duchenne muscular dystrophy (DMD) and stress urinary incontinence.

Ostarine has been the subject of FDA warning letters to marketers of dietary supplements, including a party in the case before the U.S. Court of Appeals for the Ninth Circuit: IronMag Labs LLC. In a complaint, Nutrition Distribution, also known as Athletic Xtreme, accused IronMag Labs, its CEO Robert DiMaggio and IronMag Research of violating the federal Lanham Act, a federal statute governing unfair competition, and California law through false and misleading statements about products (OSTA RX and Super DMZ 4.0) containing ostarine.

In 2016, U.S. District Judge Manuel L. Real held FDA hadn't made a final determination whether ostarine was a new drug under the Federal Food, Drug & Cosmetic Act (FDCA).

"Without a final determination or any clear statement by the FDA on this issue, the court or a jury, would have to apply the FDCA definitions to the substances at issue to determine whether OSTA RX and Super DMZ 4.0 are or contain a new or prescription drug that may not be sold or included in a dietary supplement," the judge wrote in his order, granting defendants? motion to dismiss Nutrition Distribution's lawsuit. "Such an expedition requires expertise and uniformity in administration, not practicable through the courts."

Arguments on Appeal

Nutrition Distribution argued a district court could decide its claims of false and misleading advertising against IronMag Labs without FDA's expertise.

"Contrary to the district court's determination, this case does not require the FDA's technical or policy expertise, and does not present an "issue of first impression" or "complicated issue" that Congress has specifically committed to the FDA, Nutrition Distribution asserted in a 31-page brief filed with the Ninth Circuit by its outside counsel, Robert Tauler, of the law firm Tauler Smith LLP. ?Rather, plaintiff?s claims solely concern defendants? false and misleading statements about their products.?

Nutrition Distribution said it could show "defendants" advertisements have misled, confused or deceived consumers through - expert testimony and consumer market data.?

In its brief and at oral arguments, Nutrition Distribution highlighted the importance of private lawsuits brought under the Lanham Act.

In POM Wonderful LLC v. Coca Cola Co., the U.S. Supreme Court recognized ?the Lanham Act and the FDCA complement each other in regulating misleading labels as each has its own scope and purpose,? Lisa Zepeda, an attorney with Tauler Smith, advised a panel of judges on the Ninth Circuit during oral arguments in December.

Michael Adams, an attorney representing IronMag Labs, also observed in a brief that the case related to a determination by a district court that ?POM could never state a Lanham Act claim because of federal preclusion.

"With primary jurisdiction, in contrast, the plaintiff is not barred from alleging a claim in the future following the agency's final determination," added Adams, a partner with the law firm Rutan & Tucker LLP.

Nutrition Distribution's appeal also involved the sufficiency of a claim brought in a first amended complaint under the Racketeer Influenced and Corrupt Organizations Act (RICO).

While the supplement company pointed to allegations that defendants? racketeering activities diverted sales to a website selling competing products, Real held Nutrition Distribution failed to sufficiently allege concrete losses. During oral arguments, Zepeda said the company could allege additional facts in support of its RICO claim.

GTx Clinical Trials

GTx weighed in on a distinct issue from the ones briefed by the parties to the litigation: the legal effect of its ongoing clinical drug trials of ostarine.

Subject to certain exceptions under federal law, compounds authorized for investigation as a new drug and the subject of substantial clinical trials made public are prohibited from being used in dietary supplements. GTx reported ostarine meets the criteria above, as confirmed by its ongoing clinical trials referenced in a 2017 FDA warning letter to IronMag Labs.

?Because ostarine is authorized for investigation as a new drug, is the subject of publicly disclosed substantial clinical investigations, and was not previously marketed as a dietary supplement or as a food, ostarine is excluded from the statutory definition of a ?dietary supplement,?? GTx proclaimed in a brief filed by its outside counsel, Gretchen Hoff Varner, of the law firm Covington & Burling LLP. ?Accordingly, the district court?s conclusion that there was a dispute about whether IronMag Labs? ostarine-containing product was a ?dietary supplement? or a ?drug? is wholly unfounded.?

In an emailed statement, Henry Doggrell, vice president, chief legal officer and secretary of GTx, reported an increase in the illegal sale of SARMs by supplement companies.

?GTx believes that supplements sold on the internet, particularly SARMs, should have greater regulatory oversight to ensure that consumers know what ingredients they are putting into their bodies, and that only safe products are being sold,? he told INSIDER. ?GTx wants product safety above all, and has begun to warn about illegal sale of SARMs.?

IronMag Labs Warning Letter

A few days after GTx filed its brief, the Ninth Circuit ordered Nutrition Distribution and IronMag Labs to address the significance of FDA's warning letter to IronMag Labs.

In response, Nutrition Distribution wrote the "letter simply confirms what is clear from the plain statutory language the ostarine products are not "dietary supplements? under the FDCA because ostarine has been authorized for investigation as a new drug and is the subject of publicly disclosed clinical investigations.?

Nutrition Distribution reiterated the district court doesn't need to determine whether the defendants? sale of ostarine violated the FDCA to rule on its claims. ?Regardless, defendants? statements about their products may still be false and misleading,? the supplement company maintained in its supplemental brief.

According to the lawsuit filed by Nutrition Distribution, IronMag Labs claimed its products provide various benefits, such as increased muscle mass and strength, without any adverse effects. However, Nutrition Distribution alleged ostarine has many published side effects.

In an advisory in October, FDA cautioned SARMs are associated with serious safety concerns, including the potential to increase the risk of heart attack and stroke, and other life-threatening reactions, like liver damage. That same month, FDA issued warning letters to three sports nutrition companies?including IronMag Labs?for distributing products that contain SARMs.

FDA warned IronMag Labs that distribution of its product, Super DMZ 4.0, violated federal law because it contained ostarine. Asked at the time to respond to the letter, DiMaggio said the product was discontinued more than two years ago and replaced with a version that didn?t contain any SARMs.

?IronMag Labs has not used a SARM in any of our products since 2015, and all of our ingredients and compounds currently used comply with all DSHEA [Dietary Supplement Health and Education Act] regulations,? he said in an emailed statement.

?In sum, the warning letter is not a final decision of the FDA that IronMag?s discontinued Super DMZ 4.0 product violates the FDCA,? IronMag Labs proclaimed in its supplemental brief. ?The warning letter obligates neither IronMag nor the FDA to take any future action. Instead, the warning letter is an intermediary step in the FDA's review of products that precedes the agency?s final determination.?

The district court judge, IronMag Labs argued, was correct to invoke primary jurisdiction as a basis to dismiss the lawsuit.

?The advertising and sale of products containing SARMs, such as ostarine, is a prime example of a technical, regulatory issue that is squarely within the jurisdiction of the FDA,? the company wrote in its supplement brief. ?The warning letter also demonstrates that the FDA is in the process of reviewing products containing ostarine. Where, as here, the agency is in the process of making a determination on a key issue in the litigation, courts find it particularly appropriate to defer to the agency.?

Oral Arguments

On Dec. 6, in Pasadena, California, a three-judge panel of the Ninth Circuit heard oral arguments in the case. Tauler said he expected the Ninth Circuit to render a decision within the next few months.

?The doctrine should only be invoked in a very limited set of circumstances, none of which exist here,? she said at oral arguments. ?The issue of whether defendants are falsely advertising products containing ostarine is not an issue of first impression and not a particularly complicated issue that is committed to the FDA.?

Added Nutrition Distribution's lawyer: "Instead, plaintiff''s claims rest on a determination of whether defendants? advertisements are likely to deceive a reasonable consumer. This is not an area requiring the FDA?s expertise, as courts are experienced and qualified in determining whether conduct is misleading.?

However, Circuit Judge Consuelo M. Callahan referenced the complaint?s allegations that IronMag?s products are misbranded prescription or new drugs under the FDCA.

?Aren?t these issues within the FDA?s regulatory authority and expertise, and if not, why not? the judge asked.

Zepeda said the allegations ?provide some context here ? but the allegations concerning the FDCA are not critical to the claims.? She said Nutrition Distribution has offered to amend the complaint to omit any references to the FDCA, if permitted by the court to do so.

Brian Berggren, an associate with Rutan & Tucker, distinguished the lawsuit against his clients from a typical false advertising case between competitors. During oral arguments, the lawyer described the complaint as one involving violations and determinations under the FDCA concerning ?whether ostarine is a new drug, a prescription drug or [has] been misbranded as a dietary supplement.? He argued the district court correctly applied primary jurisdiction.

Callahan asked Berggren about IronMag Labs? assertion that FDA?s warning letter isn?t significant for the purposes of primary judgment because it doesn't constitute a final determination by the agency. He responded, the warning letter is advisory and not formal under an FDA manual and case law.

?What that means is, while it may communicate the agency?s position on a matter, it's ? not final; it may change,? Berggren said. ?There?s no enforcement action that needs to be taken, and so, as a result of the lack of enforcement action, there?s no legal consequence that flows from the letter. There?s no rights or obligations that have been predetermined.?

He also said certain issues?such as a misclassification of an ingredient and whether something is a new drug?are ones ?firmly committed to the FDA.?

Circuit Judge Carlos T. Bea asked Berggren whether FDA would still need to make determinations if Nutrition Distribution was granted permission to amend its complaint and omit its allegations that IronMag Labs? products are misbranded as dietary supplements, and are prescription or new drugs. Berggren suggested FDA?s expertise would still be required, saying ?context in this case is important.? But Bea interjected.

Berggren responded that a determination under the FDCA is required for plaintiffs to prove an allegation that, for example, something is effective and safe. Again, Bea seemed unconvinced?the judge suggested an expert could testify on such matters.

The judge also noted the district court could have granted Nutrition Distribution permission to amend its complaint, eliminating portions of the lawsuit related to FDA?s jurisdiction.

Before the hearing was adjourned, Zepeda clarified, in response to questions from the bench, that she was requesting a reversal of the district court?s order of dismissal and permission to amend Nutrition Distribution?s complaint.

But earlier, in response to questioning from Bea, Berggren argued Nutrition Distribution waived certain rights in the case?including the right to amend its complaint.